Objective: To describe all medical patents granted
in the United States to Australian-resident inventors between 1984
and 1999.Data sources: All patent data originated from the US
Patent and Trademark Office. Data for 1984-1994 were compiled by CHI
Research Inc, and data for 1995-1999 were obtained from the Community
of Science website.Main outcome measures: Number of medical patents granted
in the US to Australian-resident inventors; assignees (owners) of
these medical patents; proportion of these medical patents related
to biotechnology.Results: From 1984 to 1999, 7835 utility patents were
granted in the US to Australian-resident inventors. Of these, 1308
patents (17%) were identified as medical patents; 489 (37%) of these
were biotechnology patents. Medical patents account for an
increasing proportion of all US patents granted to Australian
inventors, increasing from 10% in 1984 to 25% in 1999. Biotechnology
accounted for an increasing proportion of medical patents, rising
from 10% to 55% between 1984 and 1999. More than half the medical
patents are owned by commercial interests, and 33% by only 14
organisations, six of which are universities and their affiliated
institutions.Conclusion: Only a few organisations account for most of
the patenting of medical technology. The inventors and their
organisations listed on medical patents could be canvassed when
developing government policy and targeted for support in
commercialising their medical technology.

Interest in harnessing the economic value of medical technology
conceived and created in Australia has been growing.1-3 This is
reflected in the creation of Cooperative Research Centres (CRCs).
Since 1991, 67 CRCs have been created, of which 10 have a medical
focus.4 Despite these initiatives,
medical inventors, unlike sports stars, are virtually unrecognised
by the Australian public and scientific community. Where do our new
technologies in medicine come from -- industry, universities, or the
lone inventor?

We chose to study all patents for inventions (utility patents)
granted in the United States to Australian residents. These patents
are economically more significant than patents granted in
Australia, as the increased cost and effort of patenting in another
country is thought to filter out trivial inventions.5 Because of the
importance of the US market, the US is also the first country where
multinational corporations submit their patent applications
outside the patent's country of origin.6 Thus, Australian patents in
the US are arguably the most important subset of Australian patents in
other countries.7 Our aim was to describe
Australian medical patents and to compare them with non-medical
patents.

All patent data originated from the US Patent and Trademark Office. US
patents listing one or more Australian-resident inventors for
1984-1994 were compiled by Computer Horizons Incorporated (CHI)
Research Inc8 of the US and, for 1995-1999,
were updated from the Community of Science website.9 Our electronic
patent database contained the following information for each
patent:

year of patent being granted;

US patent registration number;

title of patent;

all listed inventors and assignees and their country of residence;
and

number of citations of scientific literature.

When required for classifying patents, the patent abstracts or full
patents were examined on the Internet (using the US patent
registration number) at either the US Patent and Trademark Office Web
Patent Database Centre,10 or the Delphion (formerly
IBM) Intellectual Property Network.11

Categorisation of medical patents

As there are no published guidelines for selecting medical patents,
we defined a medical patent as any technology used for:

managing patients and their illnesses, such as drugs, diagnostic
tests, surgical instruments, and rehabilitation devices (dental
technologies were excluded);

preventing illness, such as sunscreen lotion; or

medical research, such as laboratory instruments. Generic
technologies used in other fields, such as information technology,
were excluded.

Patents were classified as medical, possibly
medical or non-medical after reading the title and the
name of the assignees (owners). For all patents labelled as
possibly medical, we read the abstract, and if necessary the
complete patent, to properly classify the patent.

Medical patents related to biotechnology12 were identified
separately, and included devices, processes, DNA sequences,
transgenic animals and manufacturing processes in the medical
industry. Biotechnology patents related to other industries, such
as agriculture, mining and food processing, were excluded.

Describing inventors and assignees

The inventors and assignees on patents were sorted alphabetically in
Microsoft Excel,13 and any errors or
differences in spelling were corrected. The median number of
inventors and assignees per patent was calculated as a measure of
collaboration.

The assignees on each patent were categorised as a business,
university, government, research institute, CRC, non-government
organisation, technology transfer office, or individual.
Categorising was usually straightforward using the name of the
assignee, but, if there was uncertainty, a search was made on the
Internet using the search engine Dogpile.14

The data were stored, tabulated and graphed in Microsoft
Excel,13 and statistical analysis
was conducted using SPSS for Windows.15 The χ2 test or Fisher's
exact test was used to compare independent proportions. The
Mann-Whitney U test was used to compare medians.

Ethical issues

All the information in this study, including the names of inventors
and companies, is publicly available on numerous patent
bibliographic databases.

From 1984 to 1999, 7835 utility patents were granted in the US to
Australian-resident inventors. From examination of the title and
assignee names of these patents, 9% (673/7835) were classified as
medical and 35% (2767/7835) as possibly medical. The
abstracts of all patents classified as possibly medical were
examined, and 11% (869/7835) required the full patent to be read. In
total, 1308 (17%) Australian patents in the US were classified as
medical. Of these, 489 (37%) were biotechnology patents.

Trends in medical patenting

The annual number of patents granted in the US to Australian-resident
inventors in 1984-1999 more than doubled, rising from 310 to 800 (Box
1). During this 16-year period, the proportion of medical patents
rose from 10% (30/310) to 25% (202/800). Biotechnology accounted for
an increasing proportion of medical patents, rising from 10% (3/30)
to 55% (112/202) over the same period.

Comparison of medical and non-medical patents

In terms of inventors, medical patents were:

more likely to have multiple inventors listed, with a median of two
inventors per medical patent versus one per non-medical patent
(P < 0.001, Box 2); and

twice as likely to be part of an international collaboration, with
co-inventors who are residents of other countries in 21% (275/1308)
of medical and 10% (649/6527) of non-medical patents (P <
0.001, Box 3).

Most US patents listing Australian inventors have either an
Australian inventor or assignee owning the patent (68% for medical
and 81% for non-medical patents) (Box 3). The technology most likely
to arise from another country is that owned by an assignee in another
country and listing an inventor from another country. Thus, 15% of
medical and 7% of non-medical patents in our study may have originated
outside Australia (Box 3).

Patents are either assigned, usually to an organisation, or
unassigned (thus owned by the inventor). We found 82% of medical
patents were assigned, compared with 69% of non-medical patents
(P < 0.001, Box 2). For assigned patents, both medical and
non-medical patents usually have one assignee (Box 2). For these
assigned patents, there were three large differences, with medical
patents being (Box 4):

less likely to be owned by a
business;

four times more likely to be owned by a university; and

40 times more likely to be owned by a research institute.

Both medical and non-medical patents are increasingly owned by
business and universities, with fewer being unassigned. From 1984 to
1999, patents assigned to business increased from 49% to 63%; patents
assigned to universities increased from 2% to 7%; and unassigned
patents decreased from 36% to 20% of all patents.

Medical patents were three times as likely as non-medical patents to
quote from published scientific articles. Sixty per cent (785/1308)
of medical patents cited one or more scientific publications,
compared with only 23% (1475/6527) of non-medical patents (P
< 0.001).

Most of the 1785 medical inventors are not prolific, with 67%
(1200/1785) listed only once in 1984-1999. About 18% (318/1785) of
medical inventors are listed on three or more medical patents.
However, the 17 most prolific medical inventors (Box 5) were
responsible for 13% (169/1308) of Australian medical patents.
Eleven of these prolific inventors are clustered around four
different technologies: electromedical devices (cardiac
pacemakers and cochlear ear implants), biosensors, ribozymes, and
the relaxin gene.

Just 14 organisations own 33% (438/1308) of medical patents; six of
these organisations are Australian universities and their
affiliated institutions (Box 6). Surprisingly, 20% (264/1308) of
medical patents were owned by just five organisations: the
University of Melbourne, Telectronics, the Commonwealth
Scientific and Industrial Research Organisation (CSIRO), Biotech
Australia, and the University of New South Wales.

The three most common types of medical technologies are cardiac
pacemakers (7%), syringes or parenteral drug delivery technology
(4%), and cochlear ear implants (3%).

We believe that this is the first published report that has examined
Australian medical patents in detail. Australia, like all countries
of the Organisation for Economic Co-operation and Development
(OECD), has shown a strong rise in the number of US patents granted per
capita since the 1960s.5,16 However, Australia is
still ranked a low 16 of 20 OECD countries,7 with only a modest increase
in the proportion of utility patents granted to Australian inventors
in the US during 1984-1999 (from 0.46% [309/67200] to 0.52%
[800/153492]16).

As expected, Australia's comparative technological advantage is
found mainly in mining and agriculture. This is similar to other
resource-abundant OECD countries like Canada, Finland and
Norway.5,7 However, our study, along
with others,7,17 indicates a shift in
Australia to patenting in higher technologies. Our study suggests
that medical technology, especially medical biotechnology, is an
increasingly important part of Australia's intellectual property
portfolio. This may explain why Australia appears to be developing a
technological advantage in biotechnology and
pharmaceuticals.17 To place this trend in a
global perspective, our study would need to be repeated for other,
especially OECD, countries.

There is a dip in the total number of US patents granted to Australian
inventors from 1990 to 1993 (Box 1), possibly reflecting the economic
recession at the time. Interestingly, the trend in medical and
medical biotechnology patents did not show this decrease,
suggesting that development of such technology may be more resistant
to downturns in the economy. Another feature was the 51% jump in the
number of US patents granted to Australian inventors from 1997 to 1998
-- possibly a flow-on from the 54% increase in the number of patent
applications filed by Australians in the US between 1994 and
199818 (noting that it usually
takes two years from lodging a patent application until it is
granted19). This trend coincides
with increased research and development spending in Australia,
particularly by business (which unfortunately declined in
1996-97).20 However, these changes
may also reflect increased processing of patent applications by the
US Patent and Trademark Office7 -- the overall number of
utility patents issued jumping 32% from 111 983 in 1997 to 147 520 in
1998.16

Our study lends support to recent findings of the importance of
university-based research in underpinning high-technology
patents and industries.1,21 Universities and their
affiliated institutions:

make up more than a third of
the most prolific patenting organisations;

own an increasing proportion of US patents granted to Australian
inventors; and

are the source of 97% of the scientific articles cited in Australian
medical patents.17

These findings could be the result of Australian governments
actively encouraging universities to fund and commercialise
research and develop links to industry. The CRCs were part of such
initiatives, but the fact that only eight patents are owned by CRCs
suggests that they are not very productive in commercialising
research. However, this is difficult to judge, as the patents may be
assigned to commercial or university partners.

Our data also support the emerging ideas on the importance of clusters
of co-located industries and universities where collaboration and
competition act as constant spurs to innovation, such as is seen in
Silicon Valley in California.21 In Australia, such
clusters appear to be growing in Melbourne and Sydney for industries
in biotechnology and electromedical devices. This is demonstrated
by examining the prolific inventors and their assignees, indicating
varied links between industry and publicly funded institutions.

Strengths and weaknesses of the study

Possible weaknesses in our study relate to three areas of potential
misclassification in our patent data.

Classification of country of origin:We classified
patents as Australian if any inventor was an Australian resident.
This may result in the inclusion of technology originating in another
country but which had an Australian inventor working on it (estimated
to be about 15% for medical and 7% for non-medical patents).

Definition of medical patents:Given the absence of any
published guidelines, it could be debated whether certain
technologies are really "medical" (such as those related to
optometry and sunscreen lotions) and whether dental technologies
should have been excluded.

Classification of assignees as "business":Assignees
with a business-type suffix (ie, "Pty Ltd", "Ltd", "Corp", "Inc",
"NV", "AG" and "GMBH"), unless detected through searches on the
Internet as belonging to another category such as a technology
transfer organisation, would have been misclassified as a
business.

It is difficult to predict whether the first two potential biases
could alter our conclusions. The third may lead to an overestimation
of the number of patents owned by business. When identifying the
country of origin of a patent, the main convention is to use the
residency of the inventor16,17 rather than
assignees, partly because a large proportion of patents are
unassigned (29% in our study).

Like other technology or innovation indicators, patent statistics
have advantages and disadvantages.22,23 Our study treats all
patents as being of equal importance; however, a patent's commercial
value can vary enormously.23,24 Furthermore, patent
data do not capture all new technology, as some may not be patentable,
and patenting can vary with economic conditions and with the
strategic concerns of companies.23,24 For example,
patenting as a means of protecting intellectual property is very
important for the pharmaceutical industry but of little relevance to
the rubber industry.24 In addition, the
difficulty when describing patents owned by business is that many are
granted under the names of subsidiaries and divisions that are
different from the names of parent companies. Some companies even
actively hide emerging technologies under different company names,
so-called "submarine" patents.5,25

Possible mechanisms and implications for policymakers

Australia has a substantial and growing trade deficit in
high-technology goods,21 making it more imperative
to capture more of the economic value of Australian medical patents.
But how? First, the more prolific medical inventors and their
organisations could be canvassed when developing government policy
which may impact on the commercialisation of medical technology.
Such surveys could also identify emerging technologies, which may be
the basis of new industries, enabling government to take an
anticipatory stance on industry policy. Second, the medical
inventors and assignees could be actively targeted with assistance
in developing their medical technology.

To foster the growing culture of enterprise and innovation within
academia,4 it may be worth considering a
reward for the prolific inventors and assignees. Such rewards may
encourage other inventors and promote inventors as role models for
other scientists.

We are grateful to Associate Professors Sam Garrett-Jones and Tim
Turpin from the Centre for Research Policy at the University of
Wollongong for providing the database of Australian patents in the US
for 1984-1994, and to Ms Christine Porter, Manager of the European and
Commonwealth Office, Community of Science, for providing free
access to the US patents on their website. We would like to thank Dr Dora
Marinova from ISTP at Murdoch University and Professor Jane Marceau,
Pro Vice Chancellor (Research) at the University of Western Sydney
Macarthur, for their valuable advice. Eugen Mattes was the recipient
of an Eva K A Nelson Medical Research Scholarship from the University
of Western Australia from 1995 to 1998 and an advanced academic
registrar funded by the Royal Australian College of General
Practitioners in 1999 and the Registrar Scholarship and Research
Fund of the College in 2000. We also want to acknowledge the support of
Professor Max Kamien and the Department of General Practice,
University of Western Australia. We would also like to thank the
reviewers for their helpful comments.

Number listed
Number of individual assignees
Assignees/assigned patent (median)*

1192
448
1

4909
2309
1

6101
2701¶

* The medians were significantly
different (Mann-Whitney U test; P < 0.003). For assignees this is unlikely
to be of practical significance.  Medical and non-medical groups are significantly
different (Pearson χ2,
P < 0.001). After correcting errors or differences in spelling (16% of
medical and 9% of non-medical assignees were either misspelt or spelt differently).
§ Calculated using ratio from medical patents: there were 1785 individual
medical inventors after correcting the spelling of the initial list of 1878
individuals. So, for non-medical inventors, it was estimated that there
were 7092=7461 x (1785/1878) individuals, assuming a similar 5% difference
in spelling of the 7461 non-medical inventors listed initially. ¶Not
equal to the sum of inventors or assignees on medical and non-medical patents,
as 133 inventors and 56 assignees are on both types of patents.